Mastering mass change: how global labelling solutions can help your business
Warren Stacey, SVP global sales, PRISYM ID, explains the benefits of global labelling solutions to medical device manufacturers during changing times.
Global labelling solutions can help medical device manufacturers reduce regulatory risk, cut overhead costs and improve speed-to-market in the event of so-called ‘mass change’ events.
Change is a constant in the medical device and life science sectors, particularly so with the ever-shifting regulatory landscape. For medical device manufacturers, this creates the ongoing headache of ensuring compliance across all SKUs, set against a backdrop of increasing complexity. Recent pressures include the integration of UDI (Unique Device Identification) into labels, preparations for the forthcoming application of EU MDR (European Medical Device Regulation), management of e-publishing, the introduction of implant cards, increased demand for country-specific labelling – the pace of change is relentless.
So, what is the best approach to take? Obviously, it is crucial to consider the entirety of the end-to-end labelling process, not just the system. The aim should be to simplify, identifying the required label components and clearly defining individual responsibilities and how the information will be gathered. Your process, largely dictated by relevant regulations, will then decide the requirements. However, there are several reasons why I believe global labelling systems have the edge.
First and foremost, selecting a global labelling system purpose-built for use by the medical device and life science sectors means you get a solution designed from the outset to support electronic records, electronic signatures and audit logging, simplifying FDA 21CFR part 11 compliance. The vendor's documentation pack and IQ (Installation Qualification) and OQ (Operational Qualification) documentation will also reduce the amount of effort required to write and implement test scripts and PQs (Performance Qualification).
You are also protecting your investment by futureproofing it against further changes. The way you do this is by building effective links between data and templates. Carefully managed data within a global labelling solution can then be deployed across labels, booklets, IFUs (Instructions For Use) and any other piece of regulated content, with common language and phrases maintained in a library ready to update in response to regulatory shifts. The use of a common solution also ensures consistency across sites.
It is this data repository that will allow you to scope changes virtually instantaneously; identifying every item of content that contains a particular symbol, brand identity, authorised representative or any other criteria – your ability to include or exclude is limited only by the extent of the data at your disposal.
One of the biggest benefits of this approach is peace of mind. A manual scoping exercise will always conclude the same way, with someone asking; “Did we find all affected assets?”. Manual processes are inherently risky and leave an organisation open to recalls and the accompanying costs of relabelling and repacking, not to mention the potential for reputational damage.
Another big benefit is agility. Being able to deliver mass change at speed means a manufacturer can flex quickly to exploit new market opportunities - the creation of a new country-specific label for an existing SKU is essentially a mass change event and a global labelling solution will give you a first-mover advantage over competitors by helping you get to market sooner.
Finally, global label solutions provide opportunities to create efficiencies in production and across the supply chain. Label postponement possibilities are also unlocked, offering the potential for savings due to reduced waste and need to keep stock on hand. Printing each label at a distribution centre once the destination has been determined also means you can be confident that the included content is up to date. A simple update to an importer’s address across several SKUs can be done swiftly and you then know your products will not be delayed in customs due to an oversight.
Why then are global labelling solutions not more popular across the industry? In a survey of medical device manufacturers, PRISYM ID discovered that less than 8% of respondents have the automated software tools that allow them to update regulated content in this way. Resistance often comes from the upfront costs and the perceptions that this will require a long period of adjustment. While many organisations are wary of taking the plunge, the ROI is huge and once the global labelling solution is in place, you have a streamlined solution that will stand the test of time.
So how best should you make the case for change? Gaining buy-in from decision-makers requires trust in the ROI calculation and that requires honesty from all parties about timings and process. Inspection and authorisation might take two minutes on paper, but what is the real cost when you factor in that requests could be languishing in someone’s inbox for weeks before action?
One manufacturer with 17 sites and 17 separate software installations found that mass change capability was the decisive factor in their ROI calculation. They had four mass change events planned at a cost of $357,000 each, but by adopting a global labelling solution and centralising IT functions they could reduce this to tens of thousands of dollars… And those were just the changes they knew were in the pipeline. Ultimately, it concluded that a global approach was an investment that would pay dividends long into the future while providing increased flexibility to their business.
In short, a global labelling solution is a must for any manufacturer seeking a fast, efficient and low-risk way of negotiating regulatory change or any other mass change event. It does require some adjustment and an initial financial outlay – but the benefits over the long term are considerable, both in protecting your business against risk and giving you a competitive advantage in the marketplace.
On 14 December 2020, PRISYM ID and Network Partners hosted a webinar; Push the Button on ‘Mass Change’ Content & Labeling. You can watch a recording of the session here.